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Development of Nav1.7 Selective Inhibitors for the Treatment of Chronic Cough

Award Number: R44HL147776
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/01/2019
PERIOD OF PERFORMANCE END DATE: 04/30/2024

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Development of Nav1.7 Selective Inhibitors for the Treatment of Chronic Cough - PROJECT SUMMARY Chronic cough, or cough that persists for more than eight weeks, is a condition that is often associated with diseases such as chronic obstructive pulmonary disorder (COPD), asthma, idiopathic pulmonary fibrosis, bronchiectasis or gastroesophageal reflux disease (GERD). In other cases, the etiology is unknown, although it has been noted that the cough often first arises following a severe viral respiratory infection. Chronic cough has significant physical, psychological, social and economic consequences that negatively impact quality of life. Prevalence in the United States is as high as 11%, and in a majority of cases the condition is refractory. Compelling evidence supports the hypothesis that chronic cough arises from alterations in sensory physiology that cause hypersensitivity to previously innocuous stimuli. The voltage-gated sodium ion channel NaV1.7 is highly expressed in unmyelinated vagal nerve afferents that trigger cough through a sensorimotor reflex circuit. Results from a published pre-clinical report show that reducing expression of NaV1.7 nearly abolishes cough evoked by inhaled irritants, indicating that it is a promising target for reducing cough. SiteOne Therapeutics has discovered potent and selective small molecule inhibitors of NaV1.7 that block vagal C fiber activity in a dose-dependent manner. During a Phase 1 program, our team demonstrated that systemic administration of an isoform-selective NaV1.7 inhibitor abolishes the cough response to inhaled irritants in conscious guinea pigs. The objective of our Phase 2 program is evaluate safety, pharmacokinetic and efficacy endpoints, and to advance an inhaled NaV1.7 inhibitor into IND-enabling development as a therapeutic for chronic cough.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = -$528,789 )
2024	2022	SITEONE THERAPEUTICS, INC.	280 UTAH AVE STE 250	SOUTH SAN FRANCISCO	CA	94080	SAN MATEO	USA	Lung Diseases Research	000	3	9/12/2024	NON-COMPETING CONTINUATION	-$528,789
														Subtotal = -$528,789

Issue Date FY: 2022 ( Subtotal = $1,055,826 )
2022	2022	SITEONE THERAPEUTICS, INC.	351 EVERGREEN DR STE B-1	BOZEMAN	MT	59715	GALLATIN	USA	Lung Diseases Research	001	3	4/30/2022	NON-COMPETING CONTINUATION	$1,055,826
2022	2021	SITEONE THERAPEUTICS, INC.	351 EVERGREEN DR STE B-1	BOZEMAN	MT	59715	GALLATIN	USA	Lung Diseases Research	000	2	3/14/2022	COMPETING CONTINUATION	$0
														Subtotal = $1,055,826

Issue Date FY: 2021 ( Subtotal = $677,568 )
2021	2021	SITEONE THERAPEUTICS, INC.	351 EVERGREEN DR STE B-1	BOZEMAN	MT	59715	GALLATIN	USA	Lung Diseases Research	000	2	5/7/2021	COMPETING CONTINUATION	$677,568
														Subtotal = $677,568

Grand Total All Awards = $1,204,605

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Development of Nav1.7 Selective Inhibitors for the Treatment of Chronic Cough

Award Number: R44HL147776

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 05/01/2019

PERIOD OF PERFORMANCE END DATE: 04/30/2024

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